MAUDE Adverse Event Report: ADVIA CENTAUR® XPT BR (ASSAY FOR CA 27.29); CA 27.29 ANTIGEN IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

Advia centaur xpt br (assay for ca 27.29) patient results were reported as ca 15-3 for the time period (b)(6) 2018 through (b)(6) 2019.The physicians were informed and there were no concerns reported.The customer previously ran ca15-3 on alternate method.The advia centaur xpt br assay was installed in october 2018 and correlated to the ca 15-3 on the alternate method.The customer did not realize that these were two different assays until the review of quality control (qc) peer data as the data did not match.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant br results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00036 on march 08, 2019.On 03/11/2019 additional information: the customer was reporting samples that were run with advia centaur xpt br (ca 27.29) assay as advia centaur xpt ca15-3.The customer was previously using ca15-3 on an alternate method and the technical application specialist (tas) installed the br (ca 27.29) assay and correlated the br to the ca15-3 results from alternate method.There is an advia centaur xpt ca 15-3 assay that is available.The tas should have installed the advia centaur ca 15-3 assay.The advia centaur xpt br (ca 27.29) assay intended use is to aid in the monitoring of patients previously treated for state ii or stage iii breast cancer.The advia centaur xpt ca15-3 assay is an in vitro diagnostic test for quantitative serial determination of cancer antigen ca15-3.When used in conjunction with other clinical and diagnostic procedures, serial testing with the advia centaur ca 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated stage ii, with greater than two positive lymph nodes, or stage iii breast cancer patients.Both assays state in their ifu that "values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 15-3 and/or br is changed, the laboratory must perform additional serial testing to confirm baseline values." the side of the label of the reagent pack does state ca27.29.Therefore, the label on the reagent pack will not be updated.The advia centaur br ifu (b)(4) title states br assay for ca 27.29.The test definition states the test name as br and this cannot be edited by the customer.The only field that can be edited in the test definition is the print name and display name.Physicians have not questioned the results.The laboratory did inform the physicians of the error and there were no concerns noted by the physicians.The customer is operational.Based on the information provided, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR® XPT BR (ASSAY FOR CA 27.29)
• Type of Device: CA 27.29 ANTIGEN IMMUNOASSAY
• MDR Report Key: 8404482
• MDR Text Key: 142126461
• Report Number: 1219913-2019-00036
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 10334837
• Device Lot Number: 047232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1